Patent decision
- BL number
- O/1160/25
- Concerning rights in
- SPC/GB17/072
- Hearing Officer
- Dr R Dinham
- Decision date
- 12 December 2025
- Person(s) or Company(s) involved
- DANA-FARBER CANCER INSTITUTE, INC. & GENETICS INSTITUTE LLC
- Provisions discussed
- Regulation (EC) 469/2009 (Medicinal Products), Article 8; Human Medicines Regulations 2012
- Keywords
- Extension for Paediatric Testing, Supplementary Protection Certificates
- Related Decisions
- None
Summary
An application for a paediatric extension to granted certificate SPC/GB17/072 for the product atezolizumab was filed, but the examiner considered that it did not meet the requirements of Regulation 58A(2)(a) of the Human Medicines Regulations 2012 (“HMR”) because a statement in the MA, indicating compliance with an agreed completed Paediatric Investigation Plan (“PIP”), had not been provided. The examiner was of the view that, even though a compliance statement was provided in the EU marketing authorisation (“MA”) prior IP completion day, this compliance statement did not form part of the converted EU MA, and that a separate compliance statement issued by the MHRA was required. Without such a compliance statement, the requirements of Article 8(1)(d)(i) of the SPC Regulation could not be met, although an extension to the SPC with the territorial scope of Northern Ireland alone could be granted.
The applicant argued that, for converted EU MAs, a statement of compliance issued by the EMA prior to IP completion day can provide the basis for the grant of a paediatric SPC extension for the whole of the UK. In essence they stated that the interpretation of the relevant legislation by the IPO was not correct when read as a whole, and resulted in the removal of rights from a class of SPC holders following EU Exit. This, they argued was not something that was contemplated by the legislator when the EU withdrawal regulations were being passed.
1 The hearing officer acknowledged that there is an omission in the transitional arrangements for both the HMR and SPC Regulations regarding the status of a compliance statement that is present in an EMA prior to IP completion day, and whether that status changes post- IP completion day. Taking into account the legislative provisions both pre- and post- IP completion day, was well as transitional arrangements which were intended to provide continuity to individuals and businesses, the hearing officer agreed with the applicant that the compliance statement issued by the EMA prior to IP completion day formed part of the grandfathered MA, it being further established that the grandfathered MA SmPC included any changes that were associated with the completed PIP. As such, she concluded that the application satisfied Regulation 58A(2)(a) of the HMR, as the MA is a converted EU MA having effect after IP completion day as a UKMA(GB) granted under Regulation 49(1) of the HMR. As a result, the requirements of Article 8(1)(d)(i) were met and an extension to the SPC may be granted to the Applicant with both GB and NI territorial scope.
2 The application was remitted to the Examiner for further processing.
Full decision O/1160/25 
378Kb
